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CDSCO Manufacturing License for Cerebral perfusion catheter

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Introduction

The Central Drugs Standard Control Organization (CDSCO) is India's premier national regulatory body that oversees the quality of drugs and cosmetics available to the Indian consumer. CDSCO is chiefly responsible for the approval of new drugs, conducting clinical trials, laying down standards for drugs, and control over the quality of imported drugs in the country. With its main functions involving the regulation of medical devices, the organization plays a paramount role in protecting and promoting public health in India.

Manufacturing licenses are of utmost importance in the medical device industry. They ensure that the production process adheres to the highest safety and quality standards, thus protecting patients' well-being. One such crucial medical device in our discussion today is the Cerebral perfusion catheter. This catheter is a key device in aortic surgery and serves a significant purpose in brain protection.

For further information about CDSCO and its functions, you can refer to their official portal here.

What is Cerebral Perfusion Catheter?

A cerebral perfusion catheter is a medical device that plays a crucial role in aortic surgeries. It is primarily used for providing brain protection during profound hypothermic circulatory arrest—a surgical technique that drastically reduces body temperature and completely stops blood flow during the surgery. The principal purpose of the cerebral perfusion catheter is to ensure the brain is supplied with oxygenated blood during this process.

Commonly used during aortic surgery procedures, this device proves essential for patient survival and recovery. It is positioned within the aortic arch, and it facilitates the continuous flow of oxygenated blood to the brain.

The Role of CDSCO in Medical Device Regulation

The CDSCO, under the Ministry of Health and Family Welfare, has the primary responsibility of ensuring the safety, efficacy, and quality of medical devices in India. The organization has developed a strict regulatory framework that oversees all aspects of the medical device lifecycle, from manufacturing and distribution to usage and disposal. The CDSCO has progressively evolved its rules and regulations to match the rapid advances in medical technology and ensure the safety and well-being of the Indian populace.

How to Manufacture Cerebral Perfusion Catheter

The manufacturing of a high-risk class D device like cerebral perfusion catheter requires adherence to stringent quality standards and regulatory guidelines. The process involves stages like design, development, manufacturing, labeling, packaging and quality control.

Fees for Manufacturing License for Cerebral Perfusion Catheter

Being a class D medical device, the manufacturing license required is MD9. The fees for obtaining an MD9 license would be Rs. 50,000 for the license and Rs. 1,000 per product. You can read about the complete details for MD9 license at this link.

Why is a Manufacturing License Necessary for Cerebral Perfusion Catheter?

A manufacturing license is mandatory to manufacture any medical device in India. This is in line with the goal of ensuring utmost quality and safety in the production process of medical devices. Regulatory compliance plays a substantial role in the healthcare sector. It helps protect consumers and patients from substandard products by promoting a culture of compliance and transparency.

Steps to Obtain a CDSCO Manufacturing License for Cerebral Perfusion Catheter

The steps to obtain a manufacturing license for a cerebral perfusion catheter involve the following:

  1. Submitting Device Master File, Quality Management Certificate, Device Details, Site details, and other relevant documentation
  2. Applying through CDSCO's online portal.
  3. Undergoing initial assessment and licensing review.
  4. Overcoming challenges in the licensing process by consulting with experts in the field.

Frequently Asked Questions (FAQs)

Q1: What is the risk class of Cerebral Perfusion Catheter as per Medical Device Rules, 2017?

Cerebral Perfusion Catheter falls under risk class D as per the Medical Device Rules, 2017.

Q2: Which license is needed to manufacture Cerebral Perfusion Catheters?

To manufacture Cerebral Perfusion Catheters, you require an MD9 license.

Q3: What is the fee for an MD9 license for a Cerebral Perfusion Catheter?

The fee for acquiring an MD9 license to manufacture Cerebral Perfusion Catheters is Rs. 50,000 for the license and Rs. 1,000 per product.

Q4: Who will issue the manufacturing license for Cerebral Perfusion Catheters?

The CDSCO Head Quarters in New Delhi will issue the manufacturing license for Cerebral Perfusion Catheters.

Q5: Is repackaging of Cerebral Perfusion Catheters considered manufacturing?

Yes, as per Drugs and Cosmetics Act's definition of manufacturing and subsequent definitions within the Medical Device Rules made under the Drug Act, repackaging of Cerebral Perfusion Catheters is indeed considered manufacturing. Therefore, repackaging also requires an MD9 license.

Conclusion

Obtaining a manufacturing license for medical devices, especially for high-risk devices like cerebral perfusion catheters, can be a complex process. It requires expert knowledge of the rules, documentation, and procedures involved. If you require any consultation or assistance regarding the license, Pharmadocx Consultants can provide the necessary expertise to guide you through the process. You can reach out to them by visiting their website, calling on +91-7404557227, or emailing at [email protected].

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